Protective cover set for a medical probe

ABSTRACT

A protective cover set for a medical probe that includes a joint that seals both a moisture resistant probe cover and a surrounding wrapper that provides a barrier against microbial intrusion into the space between the outer wrapper and the probe cover. The sealed joint fixes the probe cover in place in relation to the outer wrapper. In some examples, the sealed joint secures a prefabricated probe cover with a three-dimensional non-planar shape in relation to the outer wrapper.

BACKGROUND

Many medical procedures involve inserting a probe, such as a transducer,a scope, or a camera, into a body cavity and positioning the device neara region of the body to be examined. Examples of such probes includeultrasound probes (also known as “transducers”) and endoscopes. Giventhe high replacement costs of such medical devices, there is a need toprotect them against contamination from bodily fluids so they can bereused. A variety of different protective probe covers have beendeveloped to protect against biological contamination. While a probecover can prevent contamination of a medical probe during a medicalprocedure, there remains the need to protect the probe cover againstcontamination before use. For this purpose, a variety of different outerwrappers (also referred to as “overwraps”) have been designed. The outerwrappers typically consist of two rectangular plastic sheets that arejoined together to form a pouch-like enclosure that maintains a cleanenvironment for the probe cover before use.

SUMMARY

This specification describes embodiments of a protective cover set for amedical probe. Some embodiments of the protective cover set include ajoint that seals both a moisture resistant probe cover and a surroundingwrapper that provides a barrier against microbial intrusion into thespace between the outer wrapper and the probe cover. In someembodiments, the sealed joint fixes the probe cover in place in relationto the outer wrapper. In some of these embodiments, the sealed jointsecures a prefabricated probe cover with a three-dimensional non-planarshape in relation to the outer wrapper.

In some embodiments, the sealed joint defines the profile of the probecover or at least a portion of the profile of the probe cover.

Other embodiments include a peripheral sealed joint between the outerwrapper layers that circumscribes the primary sealed joint between theprobe cover and the surrounding wrapper layers to provide an additionalmicrobial barrier between the external environment and the domainbetween the probe cover and the outer wrapper.

In some embodiments, the outer wrapper is attached to the joint with alower bonding strength than the probe cover, making it easy for the userto remove the outer wrapper without damaging or contaminating the probecover.

The protective outer wrapper also can function as a storage andtransport cover by protecting the probe cover against contamination by,for example, user contact prior to use with a medical probe.

The protective cover sets disclosed herein provide efficiencies inmanufacture and in performance. For example, the use of a single bond orsealed joint to seal and/or secure the moisture resistant probe coverand the surrounding wrapper requires less labor than conventionalapproaches. In addition, the combined moisture resistance andanti-microbial properties of the probe cover and the outer wrapperenable filling the distal end of ultrasound probe cover with gel priorto packaging, without risk of package decomposition and microbialgrowth, and potential probe contamination.

In a preferred embodiment, a protective cover set for a medical probeincludes a probe cover, an outer wrapper, and a bond of four or morelayers. The probe cover includes a flexible thermoplastic polymermaterial and has a closed distal end and an open proximal end configuredto receive a working end of a medical probe. The outer wrapper includestwo protective layers on opposite sides of the probe cover. The bond offour or more layers includes two layers of the thermoplastic polymermaterial between the two protective layers, wherein the bond creates atleast one sealed joint that encloses at least a portion of the probecover between the protective layers.

In some embodiments, the probe cover includes two layers of thethermoplastic polymer material, and each of the protective layersincludes a respective thermoplastic polymer material that is differentfrom the thermoplastic polymer material of the probe cover layers.

In some examples, the bond of four or more layers adheres the two layersof the flexible thermoplastic polymer material of the probe cover to oneanother with a first bond strength, and the bond adheres a first one ofthe protective layers to an adjacent one of the two layers of theflexible thermoplastic polymer material of the probe cover with a secondbond strength, where the first bond strength is at least twice as strongas the second bond strength. In some embodiments, the bond adheres asecond one of the protective layers to an adjacent one of the two layersof the flexible thermoplastic polymer material of the probe cover with athird bond strength, where the first bond strength is at least twice asstrong as the third bond strength

In some embodiments, the bond defines a boundary of the closed distalend and two longitudinal sides of the probe cover. In some examples, thebond adheres two layers of the thermoplastic polymer material of theprobe cover with a water impermeable seal along the boundary of theclosed distal end and the two longitudinal sides of the probe cover. Insome examples, the bond adheres the two protective layers along theboundary. In some embodiments, unconnected edge portions of theprotective layers extend laterally outward beyond the boundary and arefree to move independently of one another.

In some embodiments, the bond adheres a proximal end portion of theprobe cover between proximal end portions of the protective layers. Someexamples additionally include a second sealed joint between distal endportions of the protective layers that enclose an untethered distalportion of the probe cover. In some embodiments, the bond creates, onopposite longitudinal sides of the probe cover, a first sealed joint anda second sealed joint that enclose at least a proximal portion of theprobe cover between proximal portions of the protective layers. In someembodiments, at least a distal end portion of the probe cover comprisesa three-dimensional non-planar shape configured to receive the workingend of a medical probe.

In some examples of the protective cover set, a distal portion of theprobe cover is inverted within an interior portion of the probe coverand unattached to the interior portion of the probe cover.

Some embodiments of the protective cover set further include a secondbond that physically connects a region of a first one of the twoprotective layers with an adjacent region of the probe cover to improvethe ability to hold open the probe cover for probe insertion.)). Someexamples additionally include a third bond that physically connects aregion of a second one of the two protective layers with an adjacentregion of the probe cover. In some embodiments, each of the second bondand the third bond adheres the two layers of the flexible thermoplasticpolymer material of the probe cover to one another with a first bondstrength, and the second bond adheres the first protective layer withthe adjacent region of the probe cover with a second bond strength thatis less than half the strength of the first bond strength. In someexamples, the second bond adheres the first protective layer with theadjacent region of the probe cover with a second bond strength that isless than one-tenth the strength of the first bond strength. Someexamples include one or more additional bonds that physically connectrespective regions of the first one of the two protective layers withrespective adjacent regions of the probe cover.

In some embodiments, the protective layers create a microbial barrierthat inhibits microbial intrusion between the protective layers of theouter wrapper and the probe cover. Such a barrier may be used tomaintain sterility of the cover, after a sterilization process.

In some embodiments, at least one of the protective layers includes amaterial selected from the group consisting of: plastic fibers; flashspun plastic fibers; paper; a plastic film; a multi-layer laminate; anda paper-plastic laminate.

In some embodiments, the protective layers are directly bonded togetheralong a peripheral boundary that is spaced apart from and circumscribesthe probe cover.

In some embodiments, a protective cover set for a medical probe includesa probe cover comprising two layers of a flexible thermoplastic polymermaterial, and an outer wrapper comprising a first protective layer and asecond protective layer on opposite sides of the probe cover, whereinthe first and second protective layers comprise respective materialcompositions that differ from the thermoplastic polymer material of thetwo probe cover layers. The two layers of the flexible thermoplasticpolymer material of the probe cover are bonded to one another along asealed joint with a first bond strength, and the first and secondprotective layers are bonded respectively to the adjacent ones of thetwo layers of the flexible thermoplastic polymer material of the probecover along the sealed joint with second and third bond strengthsrespectively, wherein the first bond strength is at least twice asstrong as the second and third bond strengths.

In some embodiments, a protective cover set for a medical probe includesa probe cover comprising a flexible thermoplastic polymer materialhaving a three-dimensional non-planar shape configured to receive theworking end of a medical probe, and an outer wrapper comprising outerprotective layers on opposite sides of the probe cover. The two outerprotective layers and the proximal end portion of the probe cover arebonded together along a common sealed joint that defines a profile ofthe proximal end portions of the probe cover, wherein a remainingportion of the probe cover beyond the bonded proximal end portion isunattached to the outer wrapper, and a remaining distal portion of theouter protective layers are bonded together along an extension of thesealed joint that is spaced apart from and encloses the remainingportion of the probe cover.

Other features, aspects, objects, and advantages of the subject matterdescribed in this specification will become apparent from thedescription, the drawings, and the claims.

DESCRIPTION OF DRAWINGS

FIG. 1A is a plan view of a protective cover set that includes a wrapperand a probe cover that are conjoined along a sealed joint.

FIG. 1B is an exploded cross-sectional end view of an open proximal endof the protective cover set shown in FIG. 1A.

FIG. 2A is a top view of the protective cover set shown in FIG. 1A witha top portion of the wrapper peeled back from the proximal open end ofthe underlying probe cover.

FIG. 2B is a cross-sectional end view of the proximal open end of theprotective cover set shown in FIG. 2A.

FIGS. 3A, 3B, and 3C each shows a top view of a respective cover setthat includes a different respective set of longitudinally arrangedbonds between an outer wrapper and a probe cover.

FIG. 4A is a plan view of a protective cover set that includes a wrapperand a probe cover that are conjoined along a primary sealed joint, andthat further includes a peripheral sealed joint that circumscribes theside and distal lengths of the primary sealed joint.

FIG. 4B is a cross-sectional end view of the protective cover set shownin FIG. 4A.

FIG. 5 is a plan view of a protective cover set that includes a wrapperand a probe cover that are conjoined along a primary sealed joint, andthat further includes a peripheral sealed joint that completelycircumscribes the primary sealed joint.

FIG. 6 is a perspective view of a medical probe inserted within a probecover.

FIG. 7A is a plan view of a protective cover set that includes an outerwrapper and a probe cover that are conjoined along two sealed joints.

FIG. 7B is a cross-sectional end view of an open proximal end portion ofthe protective cover set shown in FIG. 7A.

FIG. 8A is a plan view of a top protective layer overlying athree-dimensional non-planar probe cover.

FIG. 8B is an exploded cross-sectional end view of a proximal open endportion of the protective layers and the probe cover shown in FIG. 8A.

FIG. 9A is a plan view of a top protective layer overlying and bonded tothe probe cover shown in FIG. 8A along a sealed joint along which flaredportions of the proximal end of the probe cover are cropped.

FIG. 9B is a cross-sectional end view of an open proximal end portion ofthe protective layer and the probe cover shown in FIG. 9A.

FIG. 10 is diagrammatic perspective view of a medical probe insertedwithin the probe cover shown in FIG. 9B.

DETAILED DESCRIPTION

In the following description, like reference numbers are used toidentify like elements. Furthermore, the drawings are intended toillustrate major features of exemplary embodiments in a diagrammaticmanner. The drawings are not intended to depict every feature of actualembodiments nor relative dimensions of the depicted elements, and arenot drawn to scale.

FIGS. 1A, 1B, 2A, and 2B show plan and cross-sectional end views of aprotective cover set 10 for use with a medical probe, e.g., anultrasound probe (not shown). The protective cover set 10 includes topand bottom sheets or layers 12, 14 of an outer wrapper 15. The top andbottom outer wrapper layers 12, 14 are disposed on opposite sides of aprobe cover 16. The probe cover 16 has a closed distal end 18. The probecover 16 also has an open proximal end 20 that is configured to receivea working end of an elongated medical probe. In some embodiments, theprobe cover 16 is formed of two layers of a polymer. In otherembodiments, the probe cover 16 is prefabricated with athree-dimensional non-planar shape that is designed to match orotherwise accommodate the exterior size and shape of an associatedmedical probe.

Referring to FIGS. 1A and 1B, in the illustrated embodiment, the probecover 16 includes two layers 22, 24 of a flexible polymer. The twoprotective outer wrapper layers 12, 14 are disposed on opposite sides ofthe two flexible polymer layers 22, 24 of the probe cover 16. Theprotective outer wrapper layers 12, 14 and the flexible polymer layers22, 24 are bonded together along a sealed joint 26 that defines aprofile of the probe cover 16. In the embodiments disclosed herein, theprotective outer wrapper layers 12, 14 and the flexible layers 22, 24 ofthe probe cover 16 may be joined together by a heat sealed bond.

Referring to FIGS. 2A and 2B, in the illustrated embodiment, theprotective outer wrapper layers 12, 14 are attached to the sealed joint26 with a lower bonding strength than the probe cover 16, making it easyfor a user to remove the protective outer wrapper layers 12, 14 withoutdamaging or contaminating the probe cover 16.

In some embodiments, at least one of the protective layers includes amaterial selected from the group consisting of: plastic fibers; flashspun plastic fibers; paper; a plastic film; a multi-layer laminate; anda paper-plastic laminate.

In some embodiments, the protective outer wrapper layers 12, 14 areformed of plastic fibers, such as flash spun plastic fibers, which mayinclude one or more of flash spun polypropylene fibers, flash spunpolyurethane fibers, flash spun nylon fibers, flash spun polyethylenefibers, and flash spun high density polyethylene (HDPE) fibers. In someof these embodiments, the plastic fibers are flash spun using heat andpressure. In some embodiments, the thickness of the outer wrapper layers12, 14 is in the range of 2 mils to 10 mils (i.e., 0.05 mm to 0.25 mm).Utilizing wrapping layers formed from flash spun plastic fibers (e.g.,high-density polyethylene (HDPE) fibers), not only protects the probecover from physical damage but also provides an excellent microbialbarrier that inhibits microbial intrusion into the domain between theprotective outer wrapper 15 and the probe cover 16. In addition,biological contaminants generally cannot consume wrapper layers formedof plastic, nor do such wrapper layers promote the growth of biologicalcontaminants.

In some embodiments, the probe cover is formed of flexible plastic filmmaterial, which may include one or more of polyethylene, polyurethane,polypropylene, and nylon.

In some embodiments, the outer wrapper layers 12, 14 and the probe cover16 are formed from layers of different plastic compositions. Forexample, in an embodiment in which the outer wrapper layers 12, 14 areformed from polyethylene (e.g., HDPE), the probe cover 16 is formed froma polymer that is free of polyethylene, such as polyurethane,polypropylene, and nylon. In an embodiment in which the outer wrapperlayers 12, 14 include polyurethane, the probe cover 16 is formed from apolymer that is free of polyurethane, such as polyethylene,polypropylene, and nylon. In an embodiment in which the outer wrapperlayers 12, 14 include polypropylene, the probe cover 16 is formed from apolymer that is free of polypropylene, such as polyethylene,polyurethane, and nylon. In an embodiment in which the outer wrapperlayers 12, 14 include nylon, the probe cover 16 is formed from a polymerthat is free of nylon, such as polyethylene, polyurethane, andpolypropylene. Other suitable combinations of non-similar orincompatible polymers may be readily determined by those of ordinaryskill in the art

The protective cover set 10 also includes a light thermal pressure bond28 (also referred to herein as a “tack bond”) that physically connects aregion of a first one of the two outer wrapper layers 12, 14 with anadjacent region of the probe cover 16. In the illustrated embodiment,the tack bond 28 is between the proximal portion of the top outerwrapper layer 12 and the proximal portion of the underlying probe cover16. In some embodiments, the tack bond 28 adheres the first outerwrapper layer (also referred to as the first “protective layer”) withthe adjacent region of the probe cover with a bond strength that is lessthan half the strength of the bond between the probe cover layers 12,14. In some of these embodiments, the tack bond 28 adheres the firstouter wrapper layer (also referred to as the first “protective layer”)with the adjacent region of the probe cover with a bond strength that isless than one-tenth the strength of the bond between the probe coverlayers 22, 24. The tack bond 28 enables the user to easily open theproximal end 20 of the probe cover 16 by manipulating the open proximalend 20 of the top outer wrapper layer 12.

In some embodiments, the protective cover set 10 includes multiple tackbonds. For example, in addition to the tack bond 28 that is formedbetween the top layer 12 of the outer wrapper 15 and the underlyingprobe cover layer 22, some embodiments additionally include a secondtack bond between the bottom layer 14 of the outer wrapper 15 and theoverlying probe cover layer 24 to further assist the user inmanipulating the mouth portion of the probe cover to facilitate theinsertion of a medical probe into the probe cover 16.

FIGS. 3A, 3B, and 3C show top views of cover sets that include differentrespective sets of longitudinally arranged tack bonds between protectiveouter wrappers and respective probe covers.

Referring to FIG. 3A, an example of a protective cover set 36 includes aset of three circular tack bonds 30, 32, 34 of the same size anddistributed longitudinally along the length of the protective cover set36. The tack bonds 30-34 adhere local regions of the interior surface ofthe outer wrapper 38 with the exterior surface of the probe cover 40 tofacilitate opening the proximal end of the probe cover 40 and tomaintain a smooth open interior shape along the length of the probecover 40 while the user is inserting the distal end of a medical probeinto the probe cover 40.

Referring to FIG. 3B, an example of a protective cover set 42 includes aset of three progressively smaller chevron-shaped tack bonds 44, 46, 48that are distributed longitudinally from the proximal end to the distalend of the protective cover set 42. The tack bonds 44-48 adhere localregions of the interior surface of the outer wrapper 50 with localregions of the exterior surface of the probe cover 52 along the lengthof the probe cover 52 to facilitate opening the proximal end of theprobe cover and maintaining a smooth open interior shape along thelength of the probe cover 52 while the user is inserting the distal endof a medical probe into the probe cover 52. The center of each v-shapedchevron is closer to the proximal end of the protective cover set 42than the peripheral ends of the chevron (i.e., each chevron is flared inthe distal direction); this feature concentrates the force a userapplies to the open proximal end of the protective cover set 42 alongthe longitudinal direction as the user is inserting the distal end of amedical probe into the probe cover. The sizes of the chevrons areprogressively smaller from the proximal end to the distal end of theprotective cover set 42 in order to reduce the force the user needs toapply to remove the wrapper layers 50 from the probe cover 52 while theuser is inserting the distal end of a medical probe into the probe cover52.

Referring to FIG. 3C, an example of a protective cover set 54 includes aset of three progressively smaller linear tack bonds 56, 58, 60 that aredistributed longitudinally from the proximal end of the protective coverset 54 to the distal end of the protective cover set 54. The linear tackbonds 56, 58, 60 adhere the interior surface of the outer wrapper 61with the exterior surface of the probe cover 62 to facilitate openingthe proximal end of the probe cover and inserting the distal end of amedical probe. In particular, distributing the tack bonds 56-60 alongthe length of the protective cover set 54 maintains a smooth open shapealong the length of the probe cover 62 when the user is inserting thedistal end of a medical probe into the probe cover. In addition,progressively reducing the lengths of the tack bonds 56-60 from theproximal end to the distal end of the protective cover set 54 reducesthe force the user needs to apply to remove the wrapper layers 61 fromthe probe cover 62 as the user is inserting a medical probe into theprobe cover 62.

Each of the example protective cover sets 36, 42, and 54 described abovein connection with FIGS. 3A, 3B, and 3C is merely exemplary and may beconfigured differently. For example, embodiments within the scope of theclaims may include a variety of different configurations with greater orfewer features and the same or different feature sizes. For example,exemplary embodiments may include tack bonds of the same or differentshapes and/or sizes that adhere the protective cover layers of the outerwrapper to adjacent local regions of the associated probe cover. Thetack bonds may be arranged to adhere the first and second protectivecover layers to first and second layers of the associated probe cover,respectively. Multiple tack bonds may be distributed between theprotective layers of the outer wrapper and the probe cover, on one orboth sides, and in any of a variety of different arrangements, includinglongitudinally, laterally, diagonally, randomly or, pseudo-randomly.

FIGS. 4A and 4B show an embodiment of a protective cover set 64 thatincludes a peripheral sealed joint 66 that circumscribes the distal end68 and the side lengths 70, 72 of the primary sealed joint 74 that isformed between the outer wrapper layers 76, 78 and the probe cover 80.The peripheral sealed joint 66 bonds the outer wrapper layers 76, 78directly to one another to provide a second microbial inhibiting barrierbetween the external environment and the four-layer bond that forms theprimary sealed joint 74 between the probe cover layers 82, 84 and themicrobe-inhibiting outer wrapper layers 76, 78.

FIG. 5 shows a protective cover set embodiment 86 that includes aperipheral sealed joint 88 that completely circumscribes the four-layerbond that forms the primary sealed joint 74 between the outer wrapperlayers 76, 78 and the layers 82, 84 of the probe cover 80. In this way,the peripheral sealed joint 74 and the peripheral sealed joint 88jointly inhibit microbial intrusion into the space between the probecover 80 and the outer wrapping layers 76, 78.

In some embodiments, the outer wrapper layers 12, 14 are bonded to eachother along the peripheral sealed joint with a lower bonding strengththan the bonding strength between the probe cover layers 22, 24, makingit easy for the user to remove the outer wrapper while still providing amicrobial barrier between the external environment and the probe cover16. In some examples, the probe cover includes two layers of thethermoplastic polymer material, and each of the protective layerscomprises a respective thermoplastic polymer material that is differentfrom the thermoplastic polymer material of the probe cover layers. Insome examples, the bond adheres the two layers of the flexiblethermoplastic polymer material of the probe cover to one another with afirst bond strength, and the bond adheres a first one of the protectivelayers to an adjacent one of the two layers of the flexiblethermoplastic polymer material of the probe cover with a second bondstrength, where the first bond strength is at least twice as strong asthe second bond strength. In some of these examples, the bond adheres asecond one of the protective layers to an adjacent one of the two layersof the flexible thermoplastic polymer material of the probe cover with athird bond strength, where the first bond strength is at least twice asstrong as the third bond strength. In some examples, the first bondstrength is at least five times as strong as the second bond strengthand the third bond strength. In still other examples, the first bondstrength is at least ten times as strong as the second bond strength andthe third bond strength.

Referring to FIG. 6, in some embodiments, a gel 100 is placed inside inthe distal end of the probe cover 16 prior to packaging. The gel 100typically is loaded into the end of the probe cover after the sealedjoint 26 is formed between the layers 12, 14, 22, 24 of the outerwrapper 15 and the probe cover 16. In some embodiments, the gel 100 maybe, for example, an ultrasound transmission gel. Sealing the outerwrapper 15 with one or more sealed joints 26, as described above,provides an effective barrier against the intrusion of microbes into thedomain of the probe cover 16, particularly when such sealed joints areformed of plastic materials which are resistive to microbial growth. Incontrast, existing medical probe covers and protective cover sets do notprovide an effective microbial barrier between the external environmentand the probe cover 16. Additionally, many such protective cover setshave an outer layer made of paper or a paper laminate. Consequently, useof gels placed in such protective cover sets prior to packaging riskmolding/spoilage of the outer wrapper, and concomitant contamination ofthe probe covers.

Placing the gel 100 in the distal end of the probe cover 16 prior topackaging, however, provides a significant convenience for the user(e.g., a medical practitioner) by obviating the extra time and effortthat it would otherwise take to manually insert the gel 100 into theprobe cover 16. In contrast, the protective cover sets described hereinenable the user to start a medical examination without delay. In thisprocess, the user picks up a protective cover set, such as theprotective cover set 10 shown in FIGS. 1A-2B. The user manipulates theouter wrapper 15 and a proximal edge of the top wrapper layer 12 in thevicinity of the tack bond 28 to open the proximal end of the probe cover16. The user inserts a medical probe into the probe cover 16. The useradvances the distal end of the medical probe to the pre-gelled distalend of the probe cover 16. The user then lifts and removes the top layer12 of the outer wrapper 15 to expose the top layer 22 of the probe cover16. Next, the user removes the bottom layer 14 of the outer wrapper 15to expose the entire probe cover 16. As shown in FIG. 6, the user canoptionally manipulate the distal portion of the probe cover 16 to smooththe gel 100 over the tip of the medical probe 102 and remove any airbubbles. Thereafter, the user can use the medical probe 102 with thepre-gelled probe cover 16 to perform a medical examination.

In some pre-gelled protective cover set embodiments disclosed herein,the distal end of the protective cover set is folded to retain thepre-packaged gel 100 within the distal portion of the probe cover beforeuse. In some embodiments, the protective cover set is stored within asecondary outer package is formed of a material (e.g., plastic coatedaluminum foil or multilayer plastic) that has a very low moisture vaportransmission rate to protect the gel from drying out before use. Inother embodiments, the outer two layers of the protective cover set aremade from a material with a very low moisture vapor transmission rate.In some examples, the second outer packaging is designed to constrainmovement of the pre-gelled protective cover set within the package andthereby maintain the fold in the distal portion of the probe cover. Someembodiments may include a spring clip or other retention mechanism tosecure the fold at the distal end of the probe cover.

Some embodiments of the protective cover set embodiments that aredisclosed herein include one or more adhesive closures, which may beimplemented by adhesive tape closure strips or dispensed adhesive withan overlying liner. In some embodiments, one or more adhesive closuresare provided on the inside surface at the proximal end of one or both ofthe top and bottom outer wrapper layers (e.g., layers 12 and 14 in theembodiment shown in FIGS. 1A and 1B). The one or more adhesive closuresmay be used to secure one or both of the outer wrapper layers 12, 14 toa cable associated with a medical probe. In some embodiments, one ormore adhesive closures are provided on the inside surface at theproximal end of one or both of the top and bottom probe cover layers(e.g., layers 22 and 24 in the embodiment shown in FIGS. 1A and 1B). Theone or more adhesive closures may be used to secure one or both of theprobe cover layers 12, 14 to a medical probe.

FIGS. 7A and 7B show plan and cross-sectional end views of a protectivecover set 110 for use with a probe, e.g., an ultrasound probe (notshown). The protective cover set 110 includes a top layer 112 and abottom layer 114 of an outer wrapper 116 and an inner inverted probecover 118 that includes a proximal section 120 and an inverted distalsection 122. The top and bottom protective layers 112, 114 of the outerwrapper 116 are disposed on opposite sides of the probe cover 118. Theprobe cover 118 includes two layers 124, 126 of a flexible polymer. Theprotective layers 112, 114 and the portions of the flexible polymerlayers 124, 126 in the proximal section 120 of the probe cover 118 arebonded together along two sealed joints 128, 130. The sealed joints 128,130 define the profile of the proximal section 120 of the probe cover118, which includes an open proximal end 132 and an open inverted end134. The top and bottom probe cover layers 124, 126 also are joinedtogether in the distal section 122 of the probe cover 118 along a distalsealed joint 136. In some embodiments, the distal sealed joint 136 is acontinuous extension of the bonds between the flexible polymer layers124, 126 in the proximal section 120 of the probe cover 118. The distalsealed joint 136 bonds the top and bottom probe cover layers 124, 126 toone another. In some embodiments, the inverted distal section 122 of theprobe cover 118 is unattached to the outer wrapper 116 between the ends138, 140 of the sealed joints 128, 130 and the distal end 142 of theprobe cover 118.

The protective cover set 110 also includes a tack bond 144 between thedistal portion of the top outer wrapper layer 112 and the distal portionof the proximal section 120 of the probe cover 118. The tack bond 144adheres the top layer 112 of the outer wrapper 116 to a top surface 146of the non-inverted probe cover layer 120. This feature enables the userto easily open the inverted portion 134 of the probe cover 118 simply bymanipulating the outer wrapper 112 and the front edge of the opening134. In some embodiments, the protective cover set 110 includes one ormore other tack bonds.

Referring to FIGS. 8A, 8B, 9A, and 9B, there are shown plan andcross-sectional end views of a protective cover set 150 for use with aprobe, e.g., an ultrasound probe (not shown). The protective cover set150 includes top and bottom sheets or layers 152, 154 of an outerwrapper 155. In some embodiments, the outer wrapper sheets or layers152, 154 are formed of a flash spun plastic fibers of the typesdescribed above in connection with the embodiments of FIGS. 1A-2B. Theouter wrapper layers 152, 154 are disposed on opposite sides of anelongated probe cover 156. The probe cover 156 has a closed distal end158 and an open proximal end 159 that is configured to receive a workingend of an elongated medical probe. In some embodiments, the probe cover156 is prefabricated with a three-dimensional non-planar shape that isdesigned to match or otherwise accommodate the external size and shapeof an associated medical probe. As used herein, the term “prefabricated”means that the probe cover 156 is fabricated before it is joined to theouter wrapping layers 152, 154.

In the illustrated embodiment, the prefabricated probe cover 156 has anelongated tubular shape with a closed distal end 158 and an open flaredproximal end portion 160 and 161. The prefabricated probe cover 156 issealed between the two protective outer wrapper layers 152, 154 by asealed joint 162 that intersects the open flared proximal end portions160, 161 of the probe cover 156 and circumscribes the profile of theremaining portions of the probe cover 156. Along the portions of thesealed joint 162 that do not intersect the probe cover 156, the sealedjoint 162 directly bonds the outer wrapper layers 152, 154 to oneanother. Along the portions 160, 161 of the sealed joint 162 thatintersect the open flared proximal end portion 159 of the probe cover156, the sealed joint 162 bonds the outer wrapper layers 152, 154 withthe layers in the flared portion 159 of the probe cover 156 thatintersect the sealed joint 162. The sealed joint 162 fixes the probecover 156 in place in relation to the outer wrapper 155. In someembodiments, the process of forming the sealed joint 162 crops the outerflared sides at the sealed joint 162, forming portions 160 and 161, asshown in FIG. 9A. This narrows the opening 164 at the proximal end 159of the probe cover 156 and, thereby, improves the fit between the probecover 156 and the medical probe.

The protective cover set 150 also includes a tack bond 170 between theproximal portion of the top layer 152 of the outer wrapper 155 and theproximal portion of the probe cover 156. The tack bond 170 providesfrictional or gripping features on the surface of the top layer 152 ofthe outer wrapper that are adhered to a top surface 171 at the proximalend 159 of the probe cover 156. This feature enables the user to easilyopen the proximal end 159 of the probe cover 96 simply by manipulatingthe outer wrapper 155 and the front edge of the proximal end 159 of thetop layer 152 of the outer wrapper 155. In some embodiments, theprotective cover set 150 includes a second tack bond 172 on the bottomside of the protective cover set 150.

Referring to FIGS. 9A and 10, in some embodiments of the protectivecover set 150, a gel 180 is placed in the distal end of the probe cover156 either before, during, or after the sealed joint 162 between theouter wrapper layers 152, 154 and the probe cover is formed. In someembodiments, the gel 180 may be, for example, an ultrasound transmissiongel. In the illustrated embodiment, the probe cover 156 with thenarrowed opening 164 covers the medical probe 166 to protect it fromcontamination.

The details of specific implementations described herein may be specificto particular embodiments of particular inventions and should not beconstrued as limitations on the scope of any claimed invention. Forexample, features that are described in connection with separateembodiments may also be incorporated into a single embodiment, andfeatures that are described in connection with a single embodiment mayalso be implemented in multiple separate embodiments. In addition, thedisclosure of steps, tasks, operations, or processes being performed ina particular order does not necessarily require that those steps, tasks,operations, or processes be performed in the particular order; instead,in some cases, one or more of the disclosed steps, tasks, operations,and processes may be performed in a different order or in accordancewith a multi-tasking schedule or in parallel.

Other embodiments are within the scope of the claims.

The invention claimed is:
 1. A protective cover set for a medical probe,comprising: a probe cover comprising two layers of flexiblethermoplastic polymer material joined together along a boundary, theprobe cover having a closed distal end and an open proximal endconfigured to receive a working end of a medical probe; an outer wrappercomprising two protective layers on opposite sides of the probe cover;and a bond of four or more layers, the bond adhering the two layers ofthe thermoplastic polymer material to one another along the boundary ofthe probe cover with a first bond strength, the bond further adhering afirst one of the two protective layers to an adjacent one of the twolayers of the thermoplastic polymer material of the probe cover alongthe boundary of the probe cover with a second bond strength that is lessthan the first bond strength.
 2. The protective cover set of claim 1,wherein each of the protective layers comprises a respectivethermoplastic polymer material that is different from the thermoplasticpolymer material of the probe cover layers.
 3. The protective cover setof claim 2, wherein the first bond strength is at least twice as strongas the second bond strength.
 4. The protective cover set of claim 3,wherein the bond adheres a second one of the protective layers to anadjacent one of the two layers of the flexible thermoplastic polymermaterial of the probe cover with a third bond strength, wherein thefirst bond strength is at least twice as strong as the third bondstrength.
 5. The protective cover set of claim 1, wherein the boundarydefines the closed distal end and two longitudinal sides of the probecover.
 6. The protective cover set of claim 1, wherein the bond adherestwo layers of the thermoplastic polymer material of the probe cover witha water impermeable seal along the boundary of the closed distal end andthe two longitudinal sides of the probe cover.
 7. The protective coverset of claim 5, wherein unconnected edge portions of the protectivelayers extend laterally outward beyond the boundary and are free to moveindependently of one another.
 8. The protective cover set of claim 1,wherein the bond adheres a proximal end portion of the probe coverbetween proximal end portions of the protective layers; and furthercomprising a second sealed joint between distal end portions of theprotective layers that enclose an untethered distal portion of the probecover.
 9. The protective cover set of claim 8, wherein the bond creates,on opposite longitudinal sides of the probe cover, a first sealed jointand a second sealed joint that enclose at least a proximal portion ofthe probe cover between proximal portions of the protective layers. 10.The protective cover set of claim 8, wherein at least a distal endportion of the probe cover comprises a three-dimensional non-planarshape configured to receive the working end of a medical probe.
 11. Theprotective cover set of claim 1, wherein a distal portion of the probecover is inverted within an interior portion of the probe cover andunattached to the interior portion of the probe cover.
 12. Theprotective cover set of claim 1, further comprising a second bond thatphysically connects a region of a first one of the two protective layerswith an adjacent region of the probe cover.
 13. The protective cover setof claim 12, further comprising a third bond that physically connects aregion of a second one of the two protective layers with an adjacentregion of the probe cover.
 14. The protective cover set of claim 12,further comprising one or more additional bonds that physically connectrespective regions of the first one of the two protective layers withrespective adjacent regions of the probe cover.
 15. The protective coverset of claim 1, wherein the protective layers create a microbial barrierthat inhibits microbial intrusion between the protective layers of theouter wrapper and the probe cover.
 16. The protective cover set of claim1, wherein at least one of the protective layers comprises a materialselected from the group consisting of: plastic fibers; flash spunplastic fibers; paper; a plastic film; a multi-layer laminate; and apaper-plastic laminate.
 17. The protective cover set of claim 1, whereinthe protective layers are directly bonded together along a peripheralboundary that is spaced apart from and circumscribes the probe cover.